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Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies.

Mohr DC, Schueller SM, Riley WT, Brown CH, Cuijpers P, Duan N, Kwasny MJ, Stiles-Shields C, Cheung K - J. Med. Internet Res. (2015)

Bottom Line: In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation.Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited.We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency.

View Article: PubMed Central - HTML - PubMed

Affiliation: Center for Behavioral Intervention Technologies (CBITs), Northwestern University, Chicago, IL, United States. d-mohr@northwestern.edu.

ABSTRACT
In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.

No MeSH data available.


BIT Model in the context of TIPs.
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Related In: Results  -  Collection

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figure2: BIT Model in the context of TIPs.

Mentions: Figure 2 places the BIT Model into the context of TIPs. Aspects included within the dotted box are the main focus of the TIP and therefore should not be changed during the course of the trial. The box on the left, labeled “BIT”, represents the instantiation features of the BIT, which define the intervention as deployed.


Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies.

Mohr DC, Schueller SM, Riley WT, Brown CH, Cuijpers P, Duan N, Kwasny MJ, Stiles-Shields C, Cheung K - J. Med. Internet Res. (2015)

BIT Model in the context of TIPs.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4526981&req=5

figure2: BIT Model in the context of TIPs.
Mentions: Figure 2 places the BIT Model into the context of TIPs. Aspects included within the dotted box are the main focus of the TIP and therefore should not be changed during the course of the trial. The box on the left, labeled “BIT”, represents the instantiation features of the BIT, which define the intervention as deployed.

Bottom Line: In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation.Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited.We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency.

View Article: PubMed Central - HTML - PubMed

Affiliation: Center for Behavioral Intervention Technologies (CBITs), Northwestern University, Chicago, IL, United States. d-mohr@northwestern.edu.

ABSTRACT
In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.

No MeSH data available.